Known bladder endoprostheses comprise a casing made of biocompatible and biodegradable material. The casing defines, at its interior, an enclosure for containing urine.
By way of example, the casing is made of PGA fiber fabric.
In order to give the casing the necessary structural rigidity, the known endoprosthesis comprises structural elements applied externally on the casing itself.
By way of example, the structural elements comprise a plurality of arms connected to each other to define an asterisk configuration and shaped so as to have dome-like form.
The structural elements are made of rigid biocompatible and biodegradable material. By way of example, the structural elements are made of PGA/PLA copolymer.
The casing is sufficiently rigid so as to stably keep its shape and flexible such that it can be manually compressed to ensure that it empties.
The casing has a connection element located at a lower portion of the casing to connect with the patient's urethra. Similarly, two connection bodies are located at the top to enable connection with the ureters.
The connection element and bodies are also obtained with the biodegradable material.
Following the implant of the endoprosthesis in the patient, there is the formation of a musculo-fibrous tissue layer or fibrous capsule (not impermeable) around the casing, while the latter decomposes. In such a manner, a neobladder is generated around the endoprosthesis.
During the resorption, there is the formation of a transition epithelium layer, which is also called urothelium, which is advantageously impermeable. This is essential for ensuring the correct functioning of the prosthesis and of the neobladder that is being formed.
The obtainment of this type of endoprosthesis is complex and costly.
Indeed, the casing made of biocompatible and biodegradable material must be carefully coupled to the structural elements, which must in turn be precisely made and carefully shaped.
This renders the obtainment complex, long and costly. Examples of bladder endoprosthesis showing the above mentioned drawbacks are hereafter illustrated.
A known orthotopic artificial bladder endoprosthesis is disclosed in WO2014/057444 as comprising a cuff substantially rigid and shaped as a balloon and having an internal surface and an external surface defining a compartment for the containment of the urine.
Another known orthotopic artificial bladder endoprosthesis is disclosed in FR2759575 as comprising a containment element of a double layer material having an internal layer and an external layer of different materials, said materials having the double function of allowing the placing of the containment element on the patient body without rejection problems and without being damaged by the urine storing up in said containment element and, at the same time, said layers are aimed to keep the shape of the containment element itself.
Another known document, defined by WO2007/095193, discloses a bladder prosthesis defined by two hemispherical being connected one to the other and provided of external flange suitable for handling said portion before or during the surgical operation and for allowing the coupling between said two portions.
Other known technical solutions, as the one disclosed in WO2008/048764, refers to devices for performing gynecologic and urologic procedures that comprise a scaffold or frame apt to be inserted, for example, in the uteri chamber so as to distend said chamber in a way corresponding to the distention of the uteri chamber in case of liquid use and with said structure which also comprises a containment element having the uterus shape and fixed to a shaft sliding with respect to a sheat together with the containment element, said containment element that, when projecting out from the sheat, distends or expands in a radial direction so as to distend the uterus walls and allowing, in such a way, the performing of procedures such as tissue removal and similar.
Another known solution is disclosed in WO2014/060911 and refers to a orthotopic artificial bladder endoprosthesis comprising two equivalent portions having a substantially semi-spherical shape and coupled together by means of resorbable suture and a frame or scaffold externally fixed to each of said two portions with the function of allowing said two portions to maintain a dome-like form even under the weight of the growing fibrous tissue.
Other known solutions for artificial bladder endoprosthesis are disclosed, for example, in WO2012/120326 which refers to an artificial bladder internally provided with a mechanical shaft apt to drive a valve for the opening/closing of the urethra.